Bi-Ostetic Cylinders BiO-DZ1030P

GUDID 00858418003393

Bi-Ostetic is a mixture with a nominal composition of 60% hydroxyapatite and 40% beta-tri-calcium phosphate. Bi-Ostetic is safe and has excellent biocompatibility. After it is implanted, the implant resorbs and is later replaced by natural bone. Bi-Ostetic is a natural choice for sparing patients the trauma of autograft harvesting. It also provides a safe alternative to human or animal cadaver bone that completely eliminates the potential for disease transmission. Bi-Ostetic is an osteoconductive bone substitute shaped as blocks (cylinders) that are intended to be used to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium. The blocks (cylinders) may be pressed into the void or into the surgical site by hand. The Bi-Ostetic blocks (cylinders) provide void filling material that acts as a temporary support medium. The blocks (cylinders) are not intended to provide structural support during the healing process. The implant is radio-opaque. Bi-Ostetic is biocompatible and resorbs in the body as bone ingrowth occurs.

BERKELEY ADVANCED BIOMATERIALS, LLC

Bone matrix implant, synthetic

• Primary Device ID: 00858418003393
• NIH Device Record Key: 6b493fc8-238a-475b-a22e-390d4fdcad3d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bi-Ostetic Cylinders
• Version Model Number: BiO-DZ1030P
• Catalog Number: BiO-DZ1030P
• Company DUNS: 081067703
• Company Name: BERKELEY ADVANCED BIOMATERIALS, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858418003393 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023703

FDA Product Code

• MQV: Filler, Bone Void, Calcium Compound

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-12-23
• Device Publish Date: 2016-04-10

On-Brand Devices [Bi-Ostetic Cylinders]

• 00858418003812: Bi-Ostetic is a mixture with a nominal composition of 60% hydroxyapatite and 40% beta-tri-calciu
• 00858418003393: Bi-Ostetic is a mixture with a nominal composition of 60% hydroxyapatite and 40% beta-tri-calciu
• 00858418003386: Bi-Ostetic is a mixture with a nominal composition of 60% hydroxyapatite and 40% beta-tri-calciu